Since the requirements are in the ISO 9001 standard this why organizations get ISO 9001 registered. ISO 9000 and ISO 9001 are interchangeable when speaking about the the requirements.

The standards are available at www.iso.org in the ISO store or at the ASQ.org Quality Press page. The ISO 9001 standard will be revised in 2015 and the draft can also be downloaded from the iso.org site. Be advised that when you download the pdf version of the standard there are restrictions on the use, printing and watermarks are added to the pdf to help copyright the documents.

Why are you doing it?﻿

Why are you getting ISO 9001 registered? There are may valid reasons to go down this path. Complying with the ISO 9001 standard is a way of establishing controls within your organization because it provides guidance in several critical areas of the organization. Sometimes customers require their vendors to become ISO 9001 registered. There are many documented cases where implementing a quality management system has saved an organization money but there are just as many organizations that found costs for implementation and registration are not worth the return. Make sure the reason why makes sense to you and the organization.

If you don't have top management's backing then getting ISO 9000 registration not even worth attempting.

COSTS!

There are many costs that are associated with implementing the ISO 9000 quality management system. The first cost is the purchase of standard itself. You can purchase the family of standards from the ISO Store. The cost for the ISO 9001:2008 standard is about $155 as of 2014 and the whole family of ISO 9000 standards is about $240.

Other costs include the development of the QMS documents, systems that are needed for compliance, and collection and analysis of data associated with requirements of the standard. This would include training and internal audits that most small businesses do not perform unless they are ISO 9001 registered. This can run into the thousands or tens of thousands of dollars if not done correctly.

The last major cost is the registration by a third party known as a Registrar. These organization are accredited by one or more countries accreditation boards. In the United States the accreditation board is the ANAB run by ANSI (American National Standards Inst.) and ASQ (American Society for Quality). Since every country has their own accreditation board they all reciprocate each others registrations. So the USA's ANAB recognizes all other countries accreditation. The cost of registration is dependent on the Registrar you choose, the size of your organization and the number of sites to be audited. Usually you will sign a three year contract with the Registrar that will include the a Phase 1 and Phase 2 audit that is required for registration and then yearly surveillance audits. You are also responsible for the travel expenses for the registrar's auditor(s) and maybe charged travel time too. The Registrar charges by the man day. Usually a rate of $800 USD to $1800 USD per man/day. Registration costs for 10 person company with one site can be $8,000 to $12,000 USD. Half of that figure paid in the first year and then the remained over the next two years. After the third year the whole thing starts all over again.

Don't get caught with an unaccredited Registrar.

ISO 9001 Elements

The ISO 9001:2008 standard is organized into 8 section known as elements. The first three sections, although important, contain information about the use of the standard. They are Section 1 - Scope, Section 2 - Normative references and Section 3 - Terms and definitions.

The requirements actually start in Section 4. The requirement elements are as follows:

Section 4 - Quality management system

These requirements are the foundation of your organization and quality management system.

Requirements include you to show how the processes of your organizartion interrelate to each other and contain requirements such how you control documents (documents that tell you what to do) and control of records (documents that prove you have done what you are supposed to do).

Section 5 - Management responsibility

Management responsibility includes establishing your organization and responsibilities, establishing performance measures, focus on the customer, conducting management meetings to see how the organization is performing and taking actions to continually improve the organization.

Section 6 - Resource management

Manage your human resources, this includes training, mange your infrastructure and work environment.

Section 7 - Product realization

These requirements are the heart of the daily activities of your organization. They include planning jobs/work, reviewing contracts, purchasing, manufacturing or providing your service and calibration requirements.

Section 8 - Measurement, analysis and improvement

These requirements include systems that collect and help you analyze and take actions to improve your organization. The requirements include monitoring or inspections of products or services, internal audits for your processes, recording and taking actions to fix nonconformances and establishing a corrective and preventive action system.